BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    MDR report key: 1001645 · Received February 18, 2008

    Report

    Report Number
    2021898-2008-00048
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K042465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT TESTED TOO HIGH PRIOR TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATA II, ADJUSTABLE DELTA VALVE, SMALL 84JXG JXG MEDTRONIC NEUROSURGERY NA C15218

    Patients

    Seq Age Sex Outcome Treatment
    1